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Clinical Trials Market ‐
Clinical Trials Market India
July 2009
Executive Summary

                Revenues from clinical trials were USD 200 mn in 2007; Expected to reach USD 500 mn by 2010
  Market        Total  536 clinical trials were conducted in India in 2008
                India’s share in global clinical trial market in 2007 was 5%  and is likely to reach 15% in 2011
                65% f li i l t i l
                 65% of clinical trials conducted in India in 2008  were Phase III trials 
                                            d t d i I di i 2008           Ph    III t i l

                 Drivers:                                                      Challenges:
  Drivers &       Cost competitiveness                                         Shortage of research professionals 
                  Disease prevalence in India
                           p                                                    Lack of data exclusivity 
                                                                                                        y
 Challenges
                  Sound medical infrastructure                                 Delays in trial approval  
                  International quality standards                              Challenges of unethical trials

                  Clinical trial can be initiated only after approval from Drugs Controller General of India (DCGI)
Government        Clinical trials are governed by Scheduled Y of Drugs and Cosmetics act and Indian Council of 
Regulations        Medical Research (ICMR) guidelines
                  Registration of trials involving humans has been made mandatory starting in June 2009 on the 
                   Clinical Trials Registry‐India (CTRI) website 
                  International pharmaceuticals companies are the major sponsors of clinical trials
                  Many Indian and foreign pharmaceutical companies have tied up with other specialist clinical 
Competition        research companies for development of new drugs
                  Internationally certified central laboratories  and research institutes also conduct clinical trials in 
                   India
                  Some of the leading CROs in India include Vimta Labs, Synchron, Reliance Clinical Research

                                          CLINICAL TRIALS MARKET – INDIA.PPT                                             2
•Introduction
 Introduction
•Overview
•Drivers & Challenges
•Drivers & Challenges
•Government Regulations
•Competition
•PE Investments
•Key Developments


         CLINICAL TRIALS MARKET – INDIA.PPT   3
Clinical trial is the final step in drug development process after 
 preliminary laboratory research and animal testing
                                                                                                  FDA Review              Post 
                  Pre‐clinical 
Drug discovery                         Phase I               Phase II                 Phase III      and                Marketing 
                    Testing
                                                                                                   Approval              Testing


                 Clinical trials are research studies involving humans and take place in four different phases

                   Number of Participants                             Length                                   Purpose


     Phase 1
     Phase 1                20‐80                                 Several months                  • Mainly safety



     Phase 2
     Phase 2               100‐300                           Several months to 2 years
                                                                                                  • Some short term safety but 
                                                                                                    mainly effectiveness



     Phase 3              1000‐3000                                   1‐4 years                   • Safety, dosage, effectiveness



                                                                                                  • Determine and monitor life‐cycle 
     Phase 4
     Phase 4                                                    Occurs post‐market 
                                                                       p
                            Varies                                                                  management, safety surveillance 
                                                                                                    management safety surveillance
                                                                    introduction
                                                                                                    and adverse effects


                                                 CLINICAL TRIALS MARKET – INDIA.PPT                                                 4
•Introduction
 Introduction
•Overview
•Drivers & Challenges
•Drivers & Challenges
•Government Regulations
•Competition
•Key Developments




         CLINICAL TRIALS MARKET – INDIA.PPT   5
India is fast emerging as the most preferred destination for 
clinical trials
Overview                                                             Revenues from Clinical Trials
•Clinical trial research constitutes 2/3rd of 
 R&D spending                                                            USD mn
•Low cost and speedy trials have made                                   600                                   500
 India a preferred destination for clinical                                                     +28%
                                                                        400
 trials                                                                                         200
•India’s share in global clinical trials                                200
                                                                                    70
 market is expected to increase from 5%                                    0
 in 2007 to 15% in 2011                                                            2002         2007       2010


Clinical trials phase wise India ‐2008                               Number of Clinical Trials
                       Phase 2            Total = 536
                    20%                                                   600                   +143%   536

                                                                          400
                          10% Phase 4                                                     221
             65%     2% 3%                                                200
                              Phase 1/2
   Phase 3
                             Phase 1                                           0
                                                                                         2007           2008




                                              CLINICAL TRIALS MARKET – INDIA.PPT                                    6
•Introduction
 Introduction
•Overview
•Drivers & Challenges
•Drivers & Challenges
•Government Regulations
•Competition
•PE Investments
•Key Developments


         CLINICAL TRIALS MARKET – INDIA.PPT   7
Drivers & Challenges


                                                                       Challenges

                                                                       Shortage of research professionals

   Drivers
                                                                       Lack of data exclusivity
                                                                       Lack of data exclusivity
   Cost competitiveness

                                                                       Delays in trial approval
   Vast patient population with diverse 
   number of diseases
   number of diseases
                                                                       Challenges of unethical trials
   Sound medical infrastructure


   International quality standards




                                           CLINICAL TRIALS MARKET – INDIA.PPT                               8
India offers significant cost savings in clinical trials

Cost Competitiveness                                                                                                   Impact
 • Multinational pharma companies can achieve cost savings of around 30–50% when outsourcing 
   clinical trial projects to India
                   Phase           US Costs        Indian Costs
                   Phase I         USD 20 mn       <USD 10 mn
                   Phase II        USD 50 mn       <USD 30 mn
                   Phase III       USD 100 mn      <USD 60 mn
 • Patient recruitment lead‐time is about 30‐40% lower in India compared to the US
 • In the US, it might take nearly three years to get around 100 patients to conduct trials on them, 
   in India the same number could be gathered in about six months 

          Chemist Productivity and Cost Comparison                  Overall Indexed Clinical Trial Costs
  Hrs/Week                          USD                    Germany                                                  1.20
  80                   70                                        UK                                              1.09
                               15,000   12,000
                                        12 000                   US                                           1 00
                                                                                                              1.00
  60         50                                               Spain                                         0.93
                               10,000                       Poland                                   0.77
  40                                                       Australia                               0.73
  20                            5,000                       France                                0.71
                                                  800          India                       0.56
   0                               0                          China                       0.52
           US         India               US      India
                                                  I di       Russia                   0.40
                                                                                      0 40




                                                 CLINICAL TRIALS MARKET – INDIA.PPT                                             9
Wide spectrum of diseases makes India an ideal destination for 
clinical trials
Vast patient population with diverse number of diseases                                                Impact
• India with a population of 1 bn has a broad spectrum of diseases
• Diseases like multi‐drug resistant pneumonia, hepatitis B, diabetes and some cancers are far 
  more prevalent in India than in the West
              l t i I di th i th W t
• Recent global guidelines make it mandatory to test new drugs across a variety of new gene pools,  
  making  India ideal for clinical trials

     Disease 
     Disease                                  Number of patients 
                                              Number of patients
    Asthma                                    40 mn
    Cardiovascular Diseases                   35 mn
    Diabetes                                  34 mn
    HIV/AIDS                                  4.2mn
    Cancer                                    3 mn
    Alzheimer’s                               1.5 mn
    Epileptic                                 8 mn
    Hypertension                              15% of total population
    Schizophrenia                             1% of total population
    HIV AIDS Adult prevalence rate            0.36% of total population



                                               CLINICAL TRIALS MARKET – INDIA.PPT                               10
Sound medical infrastructure has made India an ideal destination 
for clinical trials
Sound Medical Infrastructure                                                                        Impact
• India has over a million English speaking, internationally qualified doctors, nurses, and 
  support staff
• India has established world‐class expertise in complex medical practices such as Cardiac care, 
  Cosmetic surgery, Joint replacements, Neurosurgery etc
• Medical investigations are conducted using latest diagnostic equipment meeting the 
  stringent requirements of FDA

                               Indian Healthcare Infrastructure ‐ 2006
                            Public Hospitals                        4,049
                            Private Hospitals
                                       p                           11,334
                                                                     ,
                            Hospital Beds                         875,000
                            Doctors                              1,000,000
                            Medical Colleges                         221
                            New Doctors every Year                 18,000
                            Retails chemist Outlets               350,000
                            Dental Colleges                          100
                            Pharma Colleges                          150


                                                CLINICAL TRIALS MARKET – INDIA.PPT                           11
India upholds intellectual property protection as per 
international standards
International Quality Standards                                                                     Impact
• India became member of WTO in 1995 and agreed to adhere to the product patent regime by 
  2005
• Regulations passed by the government in 2005, committing itself to uphold and enforce 
  intellectual property protection as per international standards, has made the US and Europe to 
  look at the country as a preferred destination for clinical trial outsourcing
• India has been part of the many FDA and European Medicines Agency (EMEA) registration 
  studies
• The acceptance of data generated from India at all major conferences and journals proves its 
  credibility




                                              CLINICAL TRIALS MARKET – INDIA.PPT                             12
Shortage of research professionals and lack of data exclusivity 
could hamper growth in this sector
Shortage of Research Professionals                                                                       Impact
• India is facing a shortage of Good Clinical Practice (GCP) certified sites and investigators
• Over the next five years about 1,500‐2,000 good clinical practices (GCP) trained investigators 
  supported by 50,000 clinical research professionals would be required in India

                           Demand Supply Gap

           CRO Staff                                         6,000
                               1,000
                               1 000
      Other Site Staff                          4,000
                          400                                            Demand
                                       2,000                             Supply
          Investigator
                         300
        Sponsor Staff          1,000
                         200


Lack of Data Exclusivity                                                                                 Impact
• Unlike the US and EU India does not provide data exclusivity in clinical trials
  Unlike the US and EU, India does not provide data exclusivity in clinical trials
• Indian law has no statutory protection for the data that is submitted to regulatory authorities for 
  approval of any products
• Although India is a signatory to the TRIPS Agreement, no new law have been introduced to 
  p
  protect test data



                                                CLINICAL TRIALS MARKET – INDIA.PPT                                13
Delays in trial approval and challenges of unethical trials can 
slow down growth in this sector
Delays in trial approval                                                                                 Impact
• Delays in granting approvals is affecting  pharmaceutical companies and CROs in India
• Delays happens as the Drugs Controller's office depends on external experts and agencies such 
  as Indian Council of Medical Research for advice and additional permissions required for import 
  of trial samples and export of blood samples to foreign laboratories
                                       Clinical Trials Approval time
                          Months
                         10                                                   8

                          5
                                   1             1              1
                          0
                                   US           UK         Canada           India
Challenges of Unethical trials
 h ll       f     h l       l                                                                            Impact
• Supreme Court of India had  hauled up two top biotech companies  Shanta Biotech & Biocon for 
  openly conducting illegal clinical trials of new drugs on unsuspecting patients after a litigation 
  filed by Aadar Destitute and Old People's Home (an NGO)
• NGO alleged that the two companies had conducted improper clinical trials of Streptokinnese ‐ a 
  new clot‐busting drug used in heart attacks without requisite permissions, as a consequence 
  eight people lost their lives 
• Few incidents of illegal clinical trials has fueled  immense concerns of a huge public  outcry over 
  clinical trials
    li i l t i l



                                                  CLINICAL TRIALS MARKET – INDIA.PPT                              14
•Market Overview
 Market Overview
•Phases in Clinical Trials
•Drivers & Challenges
•Drivers & Challenges
•Government Regulations
•Competition
•PE Investments
•Key Developments


          CLINICAL TRIALS MARKET – INDIA.PPT   15
Trials can be initiated only after approval from Drugs Controller 
General of India (DCGI)

                          For Approval purpose clinical trials are classified into two types


                Category A
                Category A                                                                     Category B
                                                                                               Category B

                                                                     • Includes clinical trials whose protocols have been 
 • Includes clinical trials whose protocols have been 
                                                                       approved in other countries which are not listed in 
   approved by USA, UK, Switzerland, Australia, Canada, 
                                                                       category A
   Germany, South Africa, Japan or the EMEA
           y,               , p
                                                                     •R l t
                                                                       Regulatory (DCGI) turnaround time will be 8‐12 
                                                                                   (DCGI) t          d ti     ill b 8 12
 • Regulatory (DCGI) approval time is within 2‐4 weeks
                                                                       weeks

 • India has well‐defined guidelines for carrying out various phases of clinical trials
           g                             g      g                               (       )
 • These guidelines are in line with the global guidelines on clinical research (ICH‐GCP)
 • First time exposure of new drugs (of other countries) in Indian healthy volunteers is not allowed as per the 
   regulations in India
 • Clinical research organizations (CROs) have to obtain 'no objection' letter from Drugs Controller General of India 
   (DCGI) and import license to import the research drug
 • In case samples are exported outside the country an  export license is required from Directorate General of Foreign 
   Trade (DGFT)
 • Registration of trials involving humans has been made mandatory starting in June 2009 on the Clinical Trials Registry‐
   India (CTRI) website 




                                              CLINICAL TRIALS MARKET – INDIA.PPT                                              16
Schedule Y of the Drugs and Cosmetics Act applies to trials of 
new drugs
     Schedule Y of Drug and Cosmetic Act deals with regulations relating to clinical trial requirements for the 
                 import, manufacture and obtaining marketing approval for a new drug in India 

                      Based on marketing approval, drugs are classified into three categories
                      Based on marketing approval drugs are classified into three categories


       New drug substances                    New drug substances 
    discovered that are already              discovered that are not                    New drug substances 
   approved /marketed in other 
           d/     k t d i th               approved/marketed in other 
                                                  d/     k t d i th                      discovered in India
                                                                                         di       d i I di
             countries                              countries


                                                                                    • Clinical trials have to be 
                                                                                      carried out as human 
   • It is sufficient if 
                                          • Permission for clinical                   /clinical pharmacology 
     confirmatory trials (phase 
                                            trials were earlier given                 trials (phase I)
     III) are conducted to obtain 
                                            with a phase lag                        • The phase I trials are 
     data about the efficacy 
                                          • This has now being revised
                                            This has now being revised                carried out on healthy 
                                                                                      carried out on healthy
     and safety of the drug in a 
                                          • Clinical trials can now be                human volunteers 
     large number of patients 
                                            conducted concurrently                  • Purpose is to determine 
     (minimum 100, in 3‐4 
                                            with other countries                      the maximum tolerated 
     centers) 
                                                                                      dose in humans, adverse 
                                                                                      reactions, etc


                                             CLINICAL TRIALS MARKET – INDIA.PPT                                     17
ICMR guidelines seeks to ensure ethical practices and minimize 
exploitation of the participants
                        Indian Council for Medical Research (ICMR) Guidelines for clinical trials

                    •   The proposed trial should be carried out, only after approval of the DCGI
                    •   Informed consent is necessary 
   Drug trials
   Drug trials      •   First three of the four phases of clinical trials of drug require ethical clearance
                    •   The duration of time lapsing between two trials in the same volunteer should be a minimum of 3 months


                    • The first phase should involve low risk subjects
  Vaccine trials
  Vaccine trials    • Prophylactic vaccines are supposed to be given to normal subjects
                      Prophylactic vaccines are supposed to be given to normal subjects
                    • Therapeutic or curative vaccines may be given to patients suffering from particular diseases


   Surgical         • Safety data of the medical device in animals should be obtained 
 procedures/        • Phase I of drug trials is not necessary for trial on devices
medical devices     • Safety procedures to introduce a medical device in the patient should be followed


                    • In human beings, for investigation and treatment, different  radiations ‐ X‐ray, gamma rays etc can be used
Diagnostic agents   • Radiation limits for the use of such materials and X‐rays should be in accordance with the limits set forth by the 
                      regulatory authority (BARC) for such materials
                      regulatory authority (BARC) for such materials
                    • Safety measures should be taken to protect research subjects and others who may be exposed to radiation

                    • For herbal remedies and medicinal plants that are to be clinically evaluated for use in the Allopathic System 
Herbal remedies       procedures laid down by DGCI  for allopathic drugs should be followed
                    • This is not applicable for Ayurveda Siddha or Unani drugs for use in their own system or hospitals
                      This is not applicable for Ayurveda, Siddha or Unani  drugs for use in their own system or hospitals




                                                 CLINICAL TRIALS MARKET – INDIA.PPT                                                    18
•Market Overview
 Market Overview
•Phases in Clinical Trials
•Drivers & Challenges
•Drivers & Challenges
•Government Regulations
•Competition
•PE Investments
•Key Developments


          CLINICAL TRIALS MARKET – INDIA.PPT   19
Major clients for CROs are international  pharmaceutical 
companies
Overview 
•India has over 50 CROs in clinical trials                                                        Global Pharma 
•Major sponsors for clinical trials are international 
 M j            f    li i l t i l       i t    ti   l                                               Companies

 pharmaceuticals companies with huge R&D 
 spending
                                                                                                     Outsource 
     y                g p
•Many Indian and foreign pharmaceutical 
 companies have tied up with other specialist                                Drug 
 research companies for development of new                                                                         Clinical Trials
                                                                           Discovery
 drugs
•Pharma companies are leaning towards 
 Ph             i      l    i t      d
 outsourcing and concentrating on marketing 
 without spending time for drug discovery and 
 manufacturing
•Internationally certified central laboratories  and                                Research 
                                                                                                                   CROs
 research institutes also take part in clinical trials in                          Institutions
 India




                                              CLINICAL TRIALS MARKET – INDIA.PPT                                                20
Clinical Research Organizations (1/7)

        Company                      Locations                                        Business Description
        AcuNova                     Bangalore,     • Provides end‐to‐end services for Phase I ‐ IV clinical research, including Clinical 
                                    Manipal and      Trial Management, Clinical Data Management, PK/PD services and Central Lab
                                    Mangalore
                                                   • Offers services in drug discovery, medicinal chemistry, toxicology studies 
          Advinus                    Pune and      • It entered into Joint venture with Johnson and Johnson subsidiary, Ortho‐
        Therapeutic 
        Therapeutic                  Bangalore       McNeil‐Janssen Pharmaceuticals Inc in September 2008
                                                   • It has alliances for neglected diseases with Geneva based Drugs for Neglected 
                                                     Diseases initiative (DNDi) for tropical disease kala azar and anti‐malarial drugs 
                                                     with Genzyme Corp and Medicines 
                                                   • Offers lead generation and optimization and early computational chemistry 
           Aurigene                  Bangalore       aided and design, mining and screening of novel chemical entities. 
                                                   • Has worked on collaborative discovery programmes with Novo Nordisk on 
                                                     Diabetes and discovery services with  Rheosciences, Denmark
                                                   • Has a pipeline of 15 discovery programs at various stages 
                                                   • Works in product chemistry, organic synthesis, chiral synthesis technology
        Avra Labs                   Hyderabad      • Company is focusing on high‐end contract research, custom synthesis of 
                                                     complex chemicals and difficult to manufacture intermediates and APIs



Note: This list is not exhaustive

                                                          CLINICAL TRIALS MARKET – INDIA.PPT                                           21
Clinical Research Organizations (2/7)

        Company                     Locations                                        Business Description
                                                 • Offers services in Phase I/ II/ III/ IV clinical trials, post‐marketing surveillance, 
     Asian Clinical                                clinical data management, regulatory services
                                    Hyderabad
     Trials Limited                              • Entered into  strategic  alliance with  VPSCRO, a CRO based in Beijing, China to 
                                                   conduct clinical trial services in India, as well as in China in April 2008
                                                 • Bioavailability / bioequivalence, food effect, dose response, steady state, drug –
  Bioserve Clinical                                drug interaction, special populations, pharmacoscintigraphic imaging 
  Research Pvt. Ltd                 Hyderabad    • Has completed over 450 studies for various pharmaceutical sponsors
                                                 • Completed over 65, for Regulatory submission to US FDA, UK MHRA, SA MCC, 
                                                   AUS TGA, WHO, Health Canada and other agencies 
       ClinInvent                                • Provides services to the pharma, biotech and medical devices industries 
                                                                            p     ,
                                     Mumbai      • It has a tie‐up with MDS Pharma Services, a leading North American CRO
                                                 • Company plans to work on projects that involve genomics 

                                                 • Has expertise in managing several clinical trials in all major therapeutic 
                                                   categories
                                                      t     i
          Clintec
                                    Bangalore    • Its clients include pharmaceutical companies such as Abbott, Novartis, Roche 
                                                   and Wyeth and major biotech companies such as Serono and Chiron 
                                                 • Present in over 30 countries worldwide


Note: This list is not exhaustive

                                                         CLINICAL TRIALS MARKET – INDIA.PPT                                             22
Clinical Research Organizations (3/7)

        Company                      Locations                                          Business Description

       ClinWorld                                     • Provides clinical trial services, pharmaceutical and bio pharmaceutical analysis , 
                                    Mumbai and 
                                                       pre‐clinical services  and regulatory services
                                     Bangalore
                                                     • It has clients like Ciba‐Giegy, Glaxo Wellcome
                                                     • Offers services in medicinal chemistry, bioinformatics, clinical trials, custom 
                                                       synthesis and drug discovery
   GVK Biosciences                   Hyderabad       • Its clients include  Wyeth, Biogen, Merck & Co
                                                     • In March 2009, it got approval from Ministry of Health, Turkey for 
                                                       Bioequivalence Studies 
                                                     • Offers services in medicinal chemistry, custom synthesis, CRAMS
        Hikal Ltd.                                   • It has tied up with Merck and Novartis
                                                                    p
                                      Mumbai         Financials
                                                     • Reported total income of USD 67 mn and operating profit of USD 13 mn in 
                                                       FY2008
                                                     • Offers services in medicinal chemistry custom synthesis CRAMS
                                                       Offers services in medicinal chemistry, custom synthesis, CRAMS
                                    Khopoli (near    • Has alliance with Austin Chemical Company, US
      Innovasynth
                                      Mumbai)




Note: This list is not exhaustive

                                                            CLINICAL TRIALS MARKET – INDIA.PPT                                            23
Clinical Research Organizations (4/7)

        Company                      Locations                                        Business Description
                                                   • Provides services in bioinformatics, clinical trials, CRAMS, medicinal chemistry 
                                                     services, custom synthesis and drug discovery service
        Jubilant 
        J bil t
                                       Noida       • Entered into a drug development  joint venture with Lily in 2008
       Organosys
                                                   Financials
                                                   • Reported total income of USD 414 mn and operating profit of USD 91 mn in 
                                                     FY2008
                                                   • Offers services in clinical trial management, clinical data management, bio‐
                                                     statistics, medical writing, regulatory consulting, drug safety & 
         Karmic 
                                                     pharmacovigilance and bio‐analytical services across early to late phase (phase I 
      lifesciences                    Mumbai         through IV) and pre‐clinical research 
                                                   • It has strategic alliances with Strategic Capital Investments LLC and Seahorse 
                                                     Scientific Services Ltd
                                                   • Clinical development (phases I to III), regulatory affairs, clinical data 
                                    Gurgaon and      management, biostatistics and scientific programming, late phase, etc 
          Kendle
                                    Ahmedabad      • It acquired the Phase II‐IV business of Charles River Clinical Services in 2006




Note: This list is not exhaustive

                                                          CLINICAL TRIALS MARKET – INDIA.PPT                                           24
Clinical Research Organizations (5/7)

        Company                      Locations                                       Business Description
       Lambda                       Ahmedabad,    • Works on all aspects of clinical drug development including clinical trials, clinical 
     Therapeutic                    Mumbai and      laboratory, data management, bioequivalence/bioavailability studies 
     Research Ltd                     Chennai


    Lotus Labs Pvt.                  Bangalore    • Phase I to IV clinical trials including bio equivalence studies, drug storage & 
          Ltd                                       distribution, bio‐analytical and statistical services.
                                                    di t ib ti    bi       l ti l d t ti ti l         i
                                                  • Many of Lotus Labs’ submission studies have been approved by USFDA, WHO, 
                                                    EU, Canada and ANVISA
                                                  • Lotus submission studies have been submitted to over 45 countries across the 
                                                    globe
       Matrix                       Hyderabad     • Offers services in Drug Discovery, Development and Commercialization of New 
   Laboratories Ltd                                 Molecular Entities (NMEs)
                                                  • One of the largest  Active Pharma Ingredients (API) players with over 70 drug 
                                                    master files, 165 API in the market or under development
                                                    master files 165 API in the market or under development
                                                  Financials
                                                  • Reported an operating loss of USD 8333 in FY 08




Note: This list is not exhaustive

                                                         CLINICAL TRIALS MARKET – INDIA.PPT                                           25
Clinical Research Organizations (6/7)

        Company                       Locations                                         Business Description
         Parexel                    Hyderabad and    • Therapeutic expertise, clinical trials, data sciences, patient recruitment, medical 
                                      Bangalore        writing and submission, clinical logistics services 
                                                     • Operates in 69 locations throughout 52 countries around the world 
                                                     • It acquired ClinPhone a leading clinical technology firm in August 2008
      PharmaIntel                      Kolkata       • Offers services in Protocol and CRF designing ,conduct s phase II and III clinical 
                                                       trials , site management for clinical trials and monitoring ,clinical data 
                                                              ,           g                                      g,
                                                       management, post marketing surveillance study, phase IV clinical trial, medical 
                                                       writing /report writing  etc
                                                     • It is a part of KPC Life Solutions
            PPD                      Mumbai and 
                                     Mumbai and      • Provides services in preclinical/phase I, phase II‐III, post‐approval and labs
                                                       Provides services in preclinical/phase I, phase II III, post approval and  labs
                                      New Delhi      • It  entered into a  strategic collaboration with Merck & Co for vaccine testing 
                                                       and assay development  in April 2009

   Reliance Clinical                 Mumbai and      • Offers services in preclinical services, clinical pharmacology and  
       Research 
       Research                       Bangalore        pharmacokinetic services, clinical trial management and monitoring, diagnostic 
                                                       pharmacokinetic services clinical trial management and monitoring diagnostic
       Services                                        laboratory services, pathology laboratory services
                                                     • Has conducted over 120 trials, ranging from Phase 1 studies, Phase 2 to 4 
                                                       studies and bioavailability and bioequivalence studies



Note: This list is not exhaustive

                                                            CLINICAL TRIALS MARKET – INDIA.PPT                                            26
Clinical Research Organizations (7/7)

        Company                     Locations                                        Business Description

           SIRO                                  • Provides  services in all phases of clinical trials and in all key areas of the drug 
                                     Mumbai        development process 
                                                 • It has acquired mid sized European CRO Omega in April 2008
                                                 • Provides broad range of clinical research services from phase I to phase IV 
        Synchron                                 • It acquired Innovance, a start up CRO based in Ahmedabad in 2007
                                    Ahmedabad 
                                                                   p                 g
                                                 • It commenced operations in Bangkok in 2007
                                                 • Has a Joint Venture with Boston‐based Parexel International 
                                                 • Contract research and analytical testing, clinical lab – pathology services, 
                                                   analytical testing of water, food & drugs, environmental assessment
                                                 • Vimta Labs has so far conducted more than 600 BA/BE studies and clinical
                                                   Vimta  Labs has so far conducted more than  600 BA/BE studies and clinical 
    Vimta Labs Ltd
                                    Hyderabad      trials involving over 120 drugs
                                                 Financials
                                                 • Reported a Total Income : USD 18 mn and an Operating  Profit of USD 5 mn in FY 
                                                   2008




Note: This list is not exhaustive

                                                         CLINICAL TRIALS MARKET – INDIA.PPT                                            27
Clinical Research Institutes (1/3)

                Institute           Location                                        Areas of Research
     Advanced Centre for                         • At present comprises of the basic and clinical research wings and a 50‐
   Treatment, Research and          Mumbai         bed hospital
      Education in Cancer                        • Conducts research and development on cancer
                                                 • Design and development of drugs, diagnostics/vaccines right from the 
                                                   synthesis of compounds upto regulatory studies and clinical trials 
                                                 • Undertakes contractual research work
                                                 • Research activities are broadly divided into three subgroups:
     Central Drug Research 
                                    Lucknow           Drug discovery & development 
        Institute (CDRI) 
                                                      Regulatory studies
                                                      Infrastructural support groups 
                                                 • Developed a new drug to control and cure depression, the new drug 
                                                   has been found to be safer that the existing anti‐depression drugs
                                                 • Promotes research in the field of cancers 
     Institute of Cytology &                                                        p    y
                                                 • Institute undertakes multidisciplinary studies in order to understand 
                                     Noida
      Preventive Oncology                          the natural history, biological behavior and mechanisms of 
                                                   carcinogenesis 




Note: This list is not exhaustive

                                               CLINICAL TRIALS MARKET – INDIA.PPT                                       28
Clinical Research Institutes (2/3)

                Institute           Location                                         Areas of Research
                                                  • It is a National Institutes of Health (NIH) designated unit for HIV / AIDS 
    National AIDS Research                          Clinical Trials Network
                                      Pune
           Institute                              • It participates in clinical trials conducted by global networks of HIV / 
                                                    AIDS

                                    New Delhi     • This center is dedicated to provide infrastructure facilities and a 
    National Brain Research 
                                                    coordinated multidisciplinary team to work at the frontiers of 
            Center
                                                    neuroscience 
       National Institute of                      • Conducts research on acute diarrhoeal diseases of diverse etiologies 
       Cholera and Enteric           Kolkata        as well as on typhoid fever, infective hepatitis and HIV/AIDS related 
            Diseases                                epidemiological research and screening 
                                                  • The Institute specializes in advanced research addressing the basic 
                                                    mechanisms involved in body's defence and host‐pathogen 
       National Institute of        New Delhi
                                                    interactions 
          Immunology
                                                  • In a process of developing a vaccine to safeguard children from 
                                                    diarrhea caused from rotavirus, vaccine is undergoing clinical trials
                                                  • It works under the  Indian Council of Medical Research (ICMR), 
       National Institute of                        Ministry of Health and Family Welfare, Government of India
                                    Hyderabad
            Nutrition                             • Its clinical division offers  training, advisory and consultancy services 
                                                    to the government and other organizations 

Note: This list is not exhaustive

                                                CLINICAL TRIALS MARKET – INDIA.PPT                                           29
Clinical Research Institutes (3/3)

                Institute           Location                                        Areas of Research
                                                 • Since 1974, it has been functioning as a WHO Collaborating Centre for 
       National Institute of         Pune          arbovirus reference and research
         Virology (NIV)                          • NIV is also the National Monitoring Center for Influenza, Japanese 
                                                   encephalitis, Rota , Measles and Hepatitis
                                                 • A WHO Collaborating Centre for TB Research and Training 
                                                 • Has conducted randomized controlled clinical trials for treatment of 
     Tuberculosis Research                         both pulmonary and extra pulmonary TB in collaboration with various 
                                    Chennai
         Centre (TRC)                              hospitals and medical colleges
                                                 • The centre functions from three campuses at Chennai, Tiruvallur and 
                                                   Madurai 




Note: This list is not exhaustive

                                               CLINICAL TRIALS MARKET – INDIA.PPT                                     30
•Market Overview
 Market Overview
•Phases in Clinical Trials
•Drivers & Challenges
•Drivers & Challenges
•Government Regulations
•Competition
•PE Investments
•Key Developments


          CLINICAL TRIALS MARKET – INDIA.PPT   31
PE Investments

    Date       Company         Private Equity firm         Amount                             Description
30‐Apr‐2009    Karmic Life    Indian Angel Network  USD 500,000            The investments have been made for minority 
                Sciences                                                   stakes in the company 
19‐Aug ‐2008   Rubicon        Kotak Private Equity     Undisclosed         Rubicon Research is setting up a clinical trials 
               Research                                Amount              supply facility in Ambernath 
14‐Sep‐2007       Sai         Sequoia Capital India  USD 12.5 mn           Sequoia Capital India has invested in Hyderabad 
               Advantium                                                   based Sai Advantium for 18.34% stake
26‐Jun‐2006        Siro       Baring Private Equity    Undisclosed         Stake offloaded is less than 30 % 
               Clinpharm                               Amount




                                            CLINICAL TRIALS MARKET – INDIA.PPT                                                 32
•Market Overview
 Market Overview
•Phases in Clinical Trials
•Drivers & Challenges
•Drivers & Challenges
•Government Regulations
•Competition
•PE Investments
•Key Developments


          CLINICAL TRIALS MARKET – INDIA.PPT   33
Key Developments

Date            Development
22‐Jun‐09       Switzerland‐based contract research organization PFC Pharma Focus has set up an Indian subsidiary 
                with the help of Excel Life Sciences, a US firm that specialises in running trials in India 
15‐May‐09       GVK Biosciences, has entered into a strategic alliance with Excel Pharma Studies a Chinese research
                organization, to conduct clinical trials in Asia. Both the companies will help sponsors to conduct and
                manage phase II‐IV clinical trials, statistical analysis and medical writing
5 –May‐09
     y          Jubilant Organosys Ltd, through its Bangalore, based subsidiary, Jubilant Biosys Ltd, has signed a 
                           g     y           g         g                      y               y             g
                research collaboration agreement with, AstraZeneca, focused on delivering novel drug candidates into 
                the international pharmaceutical company's pre‐clinical pipeline 
10 – April‐09   Suven Life Sciences has completed its phase one multiple ascending dose study of SUVN‐502 in 
                healthy volunteers. SUVN‐502 is a potent, safe, highly selective, brain penetrant and orally active 
                antagonist at a non peripheral CNS receptor site 5‐HT6, intended for the symptomatic treatment of 
                  t     it t           i h l CNS        t it 5 HT6 i t d d f th                t    ti t t        t f
                Alzheimer's disease, Schizophrenia and other disorders of memory
23‐Jan‐09       Syngene, Biocon's (India) contract research firm, has signed a partnership deal with U.S. biotech firm
                Sapient Discovery
9‐Jan‐09        India's Ranbaxy Laboratories Ltd commenced initial‐stage clinical trials on an experimental respiratory 
                I di ' R b      L b      i Ld                 di i i l        li i l i l             i    l     i
                inflammation drug it which it is  jointly developing with Britain's GlaxoSmithKline 
29‐Sep‐08       India's Orchid Chemicals & Pharmaceuticals Ltd and U.S based Merck & Co Inc announced drug 
                discovery pact to develop new drugs to treat bacterial and fungal infections. Orchid's research unit, 
                Orchid Research Laboratories, will identify drug targets and develop them through phase II clinical 
                                              ,           y     g g                    p             g p
                trials and Merck will conduct late‐stage clinical trials and sell the drugs after regulatory approvals 


                                             CLINICAL TRIALS MARKET – INDIA.PPT                                           34
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Clinical Trials Market in India: Cost Competitiveness Drives Growth

  • 2. Executive Summary  Revenues from clinical trials were USD 200 mn in 2007; Expected to reach USD 500 mn by 2010 Market  Total  536 clinical trials were conducted in India in 2008  India’s share in global clinical trial market in 2007 was 5%  and is likely to reach 15% in 2011  65% f li i l t i l 65% of clinical trials conducted in India in 2008  were Phase III trials  d t d i I di i 2008 Ph III t i l Drivers: Challenges: Drivers &   Cost competitiveness  Shortage of research professionals   Disease prevalence in India p  Lack of data exclusivity  y Challenges  Sound medical infrastructure  Delays in trial approval    International quality standards  Challenges of unethical trials  Clinical trial can be initiated only after approval from Drugs Controller General of India (DCGI) Government   Clinical trials are governed by Scheduled Y of Drugs and Cosmetics act and Indian Council of  Regulations Medical Research (ICMR) guidelines  Registration of trials involving humans has been made mandatory starting in June 2009 on the  Clinical Trials Registry‐India (CTRI) website   International pharmaceuticals companies are the major sponsors of clinical trials  Many Indian and foreign pharmaceutical companies have tied up with other specialist clinical  Competition research companies for development of new drugs  Internationally certified central laboratories  and research institutes also conduct clinical trials in  India  Some of the leading CROs in India include Vimta Labs, Synchron, Reliance Clinical Research CLINICAL TRIALS MARKET – INDIA.PPT 2
  • 3. •Introduction Introduction •Overview •Drivers & Challenges •Drivers & Challenges •Government Regulations •Competition •PE Investments •Key Developments CLINICAL TRIALS MARKET – INDIA.PPT 3
  • 4. Clinical trial is the final step in drug development process after  preliminary laboratory research and animal testing FDA Review  Post  Pre‐clinical  Drug discovery Phase I Phase II Phase III and  Marketing  Testing Approval Testing Clinical trials are research studies involving humans and take place in four different phases Number of Participants Length Purpose Phase 1 Phase 1 20‐80 Several months • Mainly safety Phase 2 Phase 2 100‐300 Several months to 2 years • Some short term safety but  mainly effectiveness Phase 3 1000‐3000 1‐4 years • Safety, dosage, effectiveness • Determine and monitor life‐cycle  Phase 4 Phase 4 Occurs post‐market  p Varies management, safety surveillance  management safety surveillance introduction and adverse effects CLINICAL TRIALS MARKET – INDIA.PPT 4
  • 5. •Introduction Introduction •Overview •Drivers & Challenges •Drivers & Challenges •Government Regulations •Competition •Key Developments CLINICAL TRIALS MARKET – INDIA.PPT 5
  • 6. India is fast emerging as the most preferred destination for  clinical trials Overview Revenues from Clinical Trials •Clinical trial research constitutes 2/3rd of  R&D spending USD mn •Low cost and speedy trials have made  600 500 India a preferred destination for clinical  +28% 400 trials 200 •India’s share in global clinical trials  200 70 market is expected to increase from 5%  0 in 2007 to 15% in 2011 2002 2007 2010 Clinical trials phase wise India ‐2008 Number of Clinical Trials Phase 2 Total = 536 20% 600 +143% 536 400 10% Phase 4 221 65% 2% 3% 200 Phase 1/2 Phase 3 Phase 1 0 2007 2008 CLINICAL TRIALS MARKET – INDIA.PPT 6
  • 7. •Introduction Introduction •Overview •Drivers & Challenges •Drivers & Challenges •Government Regulations •Competition •PE Investments •Key Developments CLINICAL TRIALS MARKET – INDIA.PPT 7
  • 8. Drivers & Challenges Challenges Shortage of research professionals Drivers Lack of data exclusivity Lack of data exclusivity Cost competitiveness Delays in trial approval Vast patient population with diverse  number of diseases number of diseases Challenges of unethical trials Sound medical infrastructure International quality standards CLINICAL TRIALS MARKET – INDIA.PPT 8
  • 9. India offers significant cost savings in clinical trials Cost Competitiveness  Impact • Multinational pharma companies can achieve cost savings of around 30–50% when outsourcing  clinical trial projects to India Phase US Costs Indian Costs Phase I USD 20 mn <USD 10 mn Phase II USD 50 mn <USD 30 mn Phase III USD 100 mn <USD 60 mn • Patient recruitment lead‐time is about 30‐40% lower in India compared to the US • In the US, it might take nearly three years to get around 100 patients to conduct trials on them,  in India the same number could be gathered in about six months  Chemist Productivity and Cost Comparison Overall Indexed Clinical Trial Costs Hrs/Week USD Germany 1.20 80 70 UK 1.09 15,000 12,000 12 000 US 1 00 1.00 60 50 Spain 0.93 10,000 Poland 0.77 40 Australia 0.73 20 5,000 France 0.71 800 India 0.56 0 0 China 0.52 US India US India I di Russia 0.40 0 40 CLINICAL TRIALS MARKET – INDIA.PPT 9
  • 10. Wide spectrum of diseases makes India an ideal destination for  clinical trials Vast patient population with diverse number of diseases Impact • India with a population of 1 bn has a broad spectrum of diseases • Diseases like multi‐drug resistant pneumonia, hepatitis B, diabetes and some cancers are far  more prevalent in India than in the West l t i I di th i th W t • Recent global guidelines make it mandatory to test new drugs across a variety of new gene pools,   making  India ideal for clinical trials Disease  Disease Number of patients  Number of patients Asthma   40 mn Cardiovascular Diseases  35 mn Diabetes   34 mn HIV/AIDS   4.2mn Cancer   3 mn Alzheimer’s 1.5 mn Epileptic   8 mn Hypertension   15% of total population Schizophrenia 1% of total population HIV AIDS Adult prevalence rate 0.36% of total population CLINICAL TRIALS MARKET – INDIA.PPT 10
  • 11. Sound medical infrastructure has made India an ideal destination  for clinical trials Sound Medical Infrastructure Impact • India has over a million English speaking, internationally qualified doctors, nurses, and  support staff • India has established world‐class expertise in complex medical practices such as Cardiac care,  Cosmetic surgery, Joint replacements, Neurosurgery etc • Medical investigations are conducted using latest diagnostic equipment meeting the  stringent requirements of FDA Indian Healthcare Infrastructure ‐ 2006 Public Hospitals 4,049 Private Hospitals p 11,334 , Hospital Beds 875,000 Doctors 1,000,000 Medical Colleges 221 New Doctors every Year 18,000 Retails chemist Outlets 350,000 Dental Colleges 100 Pharma Colleges 150 CLINICAL TRIALS MARKET – INDIA.PPT 11
  • 12. India upholds intellectual property protection as per  international standards International Quality Standards Impact • India became member of WTO in 1995 and agreed to adhere to the product patent regime by  2005 • Regulations passed by the government in 2005, committing itself to uphold and enforce  intellectual property protection as per international standards, has made the US and Europe to  look at the country as a preferred destination for clinical trial outsourcing • India has been part of the many FDA and European Medicines Agency (EMEA) registration  studies • The acceptance of data generated from India at all major conferences and journals proves its  credibility CLINICAL TRIALS MARKET – INDIA.PPT 12
  • 13. Shortage of research professionals and lack of data exclusivity  could hamper growth in this sector Shortage of Research Professionals Impact • India is facing a shortage of Good Clinical Practice (GCP) certified sites and investigators • Over the next five years about 1,500‐2,000 good clinical practices (GCP) trained investigators  supported by 50,000 clinical research professionals would be required in India Demand Supply Gap CRO Staff 6,000 1,000 1 000 Other Site Staff 4,000 400 Demand 2,000 Supply Investigator 300 Sponsor Staff 1,000 200 Lack of Data Exclusivity Impact • Unlike the US and EU India does not provide data exclusivity in clinical trials Unlike the US and EU, India does not provide data exclusivity in clinical trials • Indian law has no statutory protection for the data that is submitted to regulatory authorities for  approval of any products • Although India is a signatory to the TRIPS Agreement, no new law have been introduced to  p protect test data CLINICAL TRIALS MARKET – INDIA.PPT 13
  • 14. Delays in trial approval and challenges of unethical trials can  slow down growth in this sector Delays in trial approval Impact • Delays in granting approvals is affecting  pharmaceutical companies and CROs in India • Delays happens as the Drugs Controller's office depends on external experts and agencies such  as Indian Council of Medical Research for advice and additional permissions required for import  of trial samples and export of blood samples to foreign laboratories Clinical Trials Approval time Months 10 8 5 1 1 1 0 US UK Canada India Challenges of Unethical trials h ll f h l l Impact • Supreme Court of India had  hauled up two top biotech companies  Shanta Biotech & Biocon for  openly conducting illegal clinical trials of new drugs on unsuspecting patients after a litigation  filed by Aadar Destitute and Old People's Home (an NGO) • NGO alleged that the two companies had conducted improper clinical trials of Streptokinnese ‐ a  new clot‐busting drug used in heart attacks without requisite permissions, as a consequence  eight people lost their lives  • Few incidents of illegal clinical trials has fueled  immense concerns of a huge public  outcry over  clinical trials li i l t i l CLINICAL TRIALS MARKET – INDIA.PPT 14
  • 15. •Market Overview Market Overview •Phases in Clinical Trials •Drivers & Challenges •Drivers & Challenges •Government Regulations •Competition •PE Investments •Key Developments CLINICAL TRIALS MARKET – INDIA.PPT 15
  • 16. Trials can be initiated only after approval from Drugs Controller  General of India (DCGI) For Approval purpose clinical trials are classified into two types Category A Category A Category B Category B • Includes clinical trials whose protocols have been  • Includes clinical trials whose protocols have been  approved in other countries which are not listed in  approved by USA, UK, Switzerland, Australia, Canada,  category A Germany, South Africa, Japan or the EMEA y, , p •R l t Regulatory (DCGI) turnaround time will be 8‐12  (DCGI) t d ti ill b 8 12 • Regulatory (DCGI) approval time is within 2‐4 weeks weeks • India has well‐defined guidelines for carrying out various phases of clinical trials g g g ( ) • These guidelines are in line with the global guidelines on clinical research (ICH‐GCP) • First time exposure of new drugs (of other countries) in Indian healthy volunteers is not allowed as per the  regulations in India • Clinical research organizations (CROs) have to obtain 'no objection' letter from Drugs Controller General of India  (DCGI) and import license to import the research drug • In case samples are exported outside the country an  export license is required from Directorate General of Foreign  Trade (DGFT) • Registration of trials involving humans has been made mandatory starting in June 2009 on the Clinical Trials Registry‐ India (CTRI) website  CLINICAL TRIALS MARKET – INDIA.PPT 16
  • 17. Schedule Y of the Drugs and Cosmetics Act applies to trials of  new drugs Schedule Y of Drug and Cosmetic Act deals with regulations relating to clinical trial requirements for the  import, manufacture and obtaining marketing approval for a new drug in India  Based on marketing approval, drugs are classified into three categories Based on marketing approval drugs are classified into three categories New drug substances  New drug substances  discovered that are already  discovered that are not  New drug substances  approved /marketed in other  d/ k t d i th approved/marketed in other  d/ k t d i th discovered in India di d i I di countries countries • Clinical trials have to be  carried out as human  • It is sufficient if  • Permission for clinical  /clinical pharmacology  confirmatory trials (phase  trials were earlier given  trials (phase I) III) are conducted to obtain  with a phase lag • The phase I trials are  data about the efficacy  • This has now being revised This has now being revised  carried out on healthy  carried out on healthy and safety of the drug in a  • Clinical trials can now be  human volunteers  large number of patients  conducted concurrently  • Purpose is to determine  (minimum 100, in 3‐4  with other countries  the maximum tolerated  centers)  dose in humans, adverse  reactions, etc CLINICAL TRIALS MARKET – INDIA.PPT 17
  • 18. ICMR guidelines seeks to ensure ethical practices and minimize  exploitation of the participants Indian Council for Medical Research (ICMR) Guidelines for clinical trials • The proposed trial should be carried out, only after approval of the DCGI • Informed consent is necessary  Drug trials Drug trials • First three of the four phases of clinical trials of drug require ethical clearance • The duration of time lapsing between two trials in the same volunteer should be a minimum of 3 months • The first phase should involve low risk subjects Vaccine trials Vaccine trials • Prophylactic vaccines are supposed to be given to normal subjects Prophylactic vaccines are supposed to be given to normal subjects • Therapeutic or curative vaccines may be given to patients suffering from particular diseases Surgical  • Safety data of the medical device in animals should be obtained  procedures/  • Phase I of drug trials is not necessary for trial on devices medical devices • Safety procedures to introduce a medical device in the patient should be followed • In human beings, for investigation and treatment, different  radiations ‐ X‐ray, gamma rays etc can be used Diagnostic agents • Radiation limits for the use of such materials and X‐rays should be in accordance with the limits set forth by the  regulatory authority (BARC) for such materials regulatory authority (BARC) for such materials • Safety measures should be taken to protect research subjects and others who may be exposed to radiation • For herbal remedies and medicinal plants that are to be clinically evaluated for use in the Allopathic System  Herbal remedies procedures laid down by DGCI  for allopathic drugs should be followed • This is not applicable for Ayurveda Siddha or Unani drugs for use in their own system or hospitals This is not applicable for Ayurveda, Siddha or Unani  drugs for use in their own system or hospitals CLINICAL TRIALS MARKET – INDIA.PPT 18
  • 19. •Market Overview Market Overview •Phases in Clinical Trials •Drivers & Challenges •Drivers & Challenges •Government Regulations •Competition •PE Investments •Key Developments CLINICAL TRIALS MARKET – INDIA.PPT 19
  • 20. Major clients for CROs are international  pharmaceutical  companies Overview  •India has over 50 CROs in clinical trials Global Pharma  •Major sponsors for clinical trials are international  M j f li i l t i l i t ti l Companies pharmaceuticals companies with huge R&D  spending Outsource  y g p •Many Indian and foreign pharmaceutical  companies have tied up with other specialist  Drug  research companies for development of new  Clinical Trials Discovery drugs •Pharma companies are leaning towards  Ph i l i t d outsourcing and concentrating on marketing  without spending time for drug discovery and  manufacturing •Internationally certified central laboratories  and  Research  CROs research institutes also take part in clinical trials in  Institutions India CLINICAL TRIALS MARKET – INDIA.PPT 20
  • 21. Clinical Research Organizations (1/7) Company Locations Business Description AcuNova Bangalore,  • Provides end‐to‐end services for Phase I ‐ IV clinical research, including Clinical  Manipal and  Trial Management, Clinical Data Management, PK/PD services and Central Lab Mangalore • Offers services in drug discovery, medicinal chemistry, toxicology studies  Advinus  Pune and  • It entered into Joint venture with Johnson and Johnson subsidiary, Ortho‐ Therapeutic  Therapeutic Bangalore McNeil‐Janssen Pharmaceuticals Inc in September 2008 • It has alliances for neglected diseases with Geneva based Drugs for Neglected  Diseases initiative (DNDi) for tropical disease kala azar and anti‐malarial drugs  with Genzyme Corp and Medicines  • Offers lead generation and optimization and early computational chemistry  Aurigene Bangalore aided and design, mining and screening of novel chemical entities.  • Has worked on collaborative discovery programmes with Novo Nordisk on  Diabetes and discovery services with  Rheosciences, Denmark • Has a pipeline of 15 discovery programs at various stages  • Works in product chemistry, organic synthesis, chiral synthesis technology Avra Labs Hyderabad • Company is focusing on high‐end contract research, custom synthesis of  complex chemicals and difficult to manufacture intermediates and APIs Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 21
  • 22. Clinical Research Organizations (2/7) Company Locations Business Description • Offers services in Phase I/ II/ III/ IV clinical trials, post‐marketing surveillance,  Asian Clinical  clinical data management, regulatory services Hyderabad Trials Limited • Entered into  strategic  alliance with  VPSCRO, a CRO based in Beijing, China to  conduct clinical trial services in India, as well as in China in April 2008 • Bioavailability / bioequivalence, food effect, dose response, steady state, drug – Bioserve Clinical  drug interaction, special populations, pharmacoscintigraphic imaging  Research Pvt. Ltd Hyderabad • Has completed over 450 studies for various pharmaceutical sponsors • Completed over 65, for Regulatory submission to US FDA, UK MHRA, SA MCC,  AUS TGA, WHO, Health Canada and other agencies  ClinInvent • Provides services to the pharma, biotech and medical devices industries  p , Mumbai • It has a tie‐up with MDS Pharma Services, a leading North American CRO • Company plans to work on projects that involve genomics  • Has expertise in managing several clinical trials in all major therapeutic  categories t i Clintec Bangalore  • Its clients include pharmaceutical companies such as Abbott, Novartis, Roche  and Wyeth and major biotech companies such as Serono and Chiron  • Present in over 30 countries worldwide Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 22
  • 23. Clinical Research Organizations (3/7) Company Locations Business Description ClinWorld • Provides clinical trial services, pharmaceutical and bio pharmaceutical analysis ,  Mumbai and  pre‐clinical services  and regulatory services Bangalore • It has clients like Ciba‐Giegy, Glaxo Wellcome • Offers services in medicinal chemistry, bioinformatics, clinical trials, custom  synthesis and drug discovery GVK Biosciences Hyderabad • Its clients include  Wyeth, Biogen, Merck & Co • In March 2009, it got approval from Ministry of Health, Turkey for  Bioequivalence Studies  • Offers services in medicinal chemistry, custom synthesis, CRAMS Hikal Ltd. • It has tied up with Merck and Novartis p Mumbai Financials • Reported total income of USD 67 mn and operating profit of USD 13 mn in  FY2008 • Offers services in medicinal chemistry custom synthesis CRAMS Offers services in medicinal chemistry, custom synthesis, CRAMS Khopoli (near  • Has alliance with Austin Chemical Company, US Innovasynth Mumbai) Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 23
  • 24. Clinical Research Organizations (4/7) Company Locations Business Description • Provides services in bioinformatics, clinical trials, CRAMS, medicinal chemistry  services, custom synthesis and drug discovery service Jubilant  J bil t Noida • Entered into a drug development  joint venture with Lily in 2008 Organosys Financials • Reported total income of USD 414 mn and operating profit of USD 91 mn in  FY2008 • Offers services in clinical trial management, clinical data management, bio‐ statistics, medical writing, regulatory consulting, drug safety &  Karmic  pharmacovigilance and bio‐analytical services across early to late phase (phase I  lifesciences Mumbai through IV) and pre‐clinical research  • It has strategic alliances with Strategic Capital Investments LLC and Seahorse  Scientific Services Ltd • Clinical development (phases I to III), regulatory affairs, clinical data  Gurgaon and  management, biostatistics and scientific programming, late phase, etc  Kendle Ahmedabad • It acquired the Phase II‐IV business of Charles River Clinical Services in 2006 Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 24
  • 25. Clinical Research Organizations (5/7) Company Locations Business Description Lambda  Ahmedabad,  • Works on all aspects of clinical drug development including clinical trials, clinical  Therapeutic  Mumbai and  laboratory, data management, bioequivalence/bioavailability studies  Research Ltd Chennai Lotus Labs Pvt.  Bangalore • Phase I to IV clinical trials including bio equivalence studies, drug storage &  Ltd distribution, bio‐analytical and statistical services. di t ib ti bi l ti l d t ti ti l i • Many of Lotus Labs’ submission studies have been approved by USFDA, WHO,  EU, Canada and ANVISA • Lotus submission studies have been submitted to over 45 countries across the  globe Matrix  Hyderabad • Offers services in Drug Discovery, Development and Commercialization of New  Laboratories Ltd Molecular Entities (NMEs) • One of the largest  Active Pharma Ingredients (API) players with over 70 drug  master files, 165 API in the market or under development master files 165 API in the market or under development Financials • Reported an operating loss of USD 8333 in FY 08 Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 25
  • 26. Clinical Research Organizations (6/7) Company Locations Business Description Parexel  Hyderabad and  • Therapeutic expertise, clinical trials, data sciences, patient recruitment, medical  Bangalore writing and submission, clinical logistics services  • Operates in 69 locations throughout 52 countries around the world  • It acquired ClinPhone a leading clinical technology firm in August 2008 PharmaIntel Kolkata • Offers services in Protocol and CRF designing ,conduct s phase II and III clinical  trials , site management for clinical trials and monitoring ,clinical data  , g g, management, post marketing surveillance study, phase IV clinical trial, medical  writing /report writing  etc • It is a part of KPC Life Solutions PPD Mumbai and  Mumbai and • Provides services in preclinical/phase I, phase II‐III, post‐approval and labs Provides services in preclinical/phase I, phase II III, post approval and  labs New Delhi • It  entered into a  strategic collaboration with Merck & Co for vaccine testing  and assay development  in April 2009 Reliance Clinical  Mumbai and  • Offers services in preclinical services, clinical pharmacology and   Research  Research Bangalore pharmacokinetic services, clinical trial management and monitoring, diagnostic  pharmacokinetic services clinical trial management and monitoring diagnostic Services laboratory services, pathology laboratory services • Has conducted over 120 trials, ranging from Phase 1 studies, Phase 2 to 4  studies and bioavailability and bioequivalence studies Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 26
  • 27. Clinical Research Organizations (7/7) Company Locations Business Description SIRO • Provides  services in all phases of clinical trials and in all key areas of the drug  Mumbai development process  • It has acquired mid sized European CRO Omega in April 2008 • Provides broad range of clinical research services from phase I to phase IV  Synchron • It acquired Innovance, a start up CRO based in Ahmedabad in 2007 Ahmedabad  p g • It commenced operations in Bangkok in 2007 • Has a Joint Venture with Boston‐based Parexel International  • Contract research and analytical testing, clinical lab – pathology services,  analytical testing of water, food & drugs, environmental assessment • Vimta Labs has so far conducted more than 600 BA/BE studies and clinical Vimta  Labs has so far conducted more than  600 BA/BE studies and clinical  Vimta Labs Ltd Hyderabad trials involving over 120 drugs Financials • Reported a Total Income : USD 18 mn and an Operating  Profit of USD 5 mn in FY  2008 Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 27
  • 28. Clinical Research Institutes (1/3) Institute Location Areas of Research Advanced Centre for  • At present comprises of the basic and clinical research wings and a 50‐ Treatment, Research and  Mumbai bed hospital Education in Cancer • Conducts research and development on cancer • Design and development of drugs, diagnostics/vaccines right from the  synthesis of compounds upto regulatory studies and clinical trials  • Undertakes contractual research work • Research activities are broadly divided into three subgroups: Central Drug Research  Lucknow  Drug discovery & development  Institute (CDRI)   Regulatory studies  Infrastructural support groups  • Developed a new drug to control and cure depression, the new drug  has been found to be safer that the existing anti‐depression drugs • Promotes research in the field of cancers  Institute of Cytology &  p y • Institute undertakes multidisciplinary studies in order to understand  Noida Preventive Oncology  the natural history, biological behavior and mechanisms of  carcinogenesis  Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 28
  • 29. Clinical Research Institutes (2/3) Institute Location Areas of Research • It is a National Institutes of Health (NIH) designated unit for HIV / AIDS  National AIDS Research  Clinical Trials Network Pune Institute • It participates in clinical trials conducted by global networks of HIV /  AIDS New Delhi • This center is dedicated to provide infrastructure facilities and a  National Brain Research  coordinated multidisciplinary team to work at the frontiers of  Center neuroscience  National Institute of  • Conducts research on acute diarrhoeal diseases of diverse etiologies  Cholera and Enteric  Kolkata as well as on typhoid fever, infective hepatitis and HIV/AIDS related  Diseases epidemiological research and screening  • The Institute specializes in advanced research addressing the basic  mechanisms involved in body's defence and host‐pathogen  National Institute of  New Delhi interactions  Immunology • In a process of developing a vaccine to safeguard children from  diarrhea caused from rotavirus, vaccine is undergoing clinical trials • It works under the  Indian Council of Medical Research (ICMR),  National Institute of  Ministry of Health and Family Welfare, Government of India Hyderabad Nutrition • Its clinical division offers  training, advisory and consultancy services  to the government and other organizations  Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 29
  • 30. Clinical Research Institutes (3/3) Institute Location Areas of Research • Since 1974, it has been functioning as a WHO Collaborating Centre for  National Institute of  Pune arbovirus reference and research Virology (NIV) • NIV is also the National Monitoring Center for Influenza, Japanese  encephalitis, Rota , Measles and Hepatitis • A WHO Collaborating Centre for TB Research and Training  • Has conducted randomized controlled clinical trials for treatment of  Tuberculosis Research  both pulmonary and extra pulmonary TB in collaboration with various  Chennai Centre (TRC)  hospitals and medical colleges • The centre functions from three campuses at Chennai, Tiruvallur and  Madurai  Note: This list is not exhaustive CLINICAL TRIALS MARKET – INDIA.PPT 30
  • 31. •Market Overview Market Overview •Phases in Clinical Trials •Drivers & Challenges •Drivers & Challenges •Government Regulations •Competition •PE Investments •Key Developments CLINICAL TRIALS MARKET – INDIA.PPT 31
  • 32. PE Investments Date Company Private Equity firm Amount Description 30‐Apr‐2009 Karmic Life  Indian Angel Network  USD 500,000 The investments have been made for minority  Sciences stakes in the company  19‐Aug ‐2008 Rubicon  Kotak Private Equity  Undisclosed  Rubicon Research is setting up a clinical trials  Research  Amount supply facility in Ambernath  14‐Sep‐2007 Sai  Sequoia Capital India  USD 12.5 mn Sequoia Capital India has invested in Hyderabad  Advantium based Sai Advantium for 18.34% stake 26‐Jun‐2006 Siro  Baring Private Equity  Undisclosed  Stake offloaded is less than 30 %  Clinpharm Amount CLINICAL TRIALS MARKET – INDIA.PPT 32
  • 33. •Market Overview Market Overview •Phases in Clinical Trials •Drivers & Challenges •Drivers & Challenges •Government Regulations •Competition •PE Investments •Key Developments CLINICAL TRIALS MARKET – INDIA.PPT 33
  • 34. Key Developments Date Development 22‐Jun‐09 Switzerland‐based contract research organization PFC Pharma Focus has set up an Indian subsidiary  with the help of Excel Life Sciences, a US firm that specialises in running trials in India  15‐May‐09 GVK Biosciences, has entered into a strategic alliance with Excel Pharma Studies a Chinese research organization, to conduct clinical trials in Asia. Both the companies will help sponsors to conduct and manage phase II‐IV clinical trials, statistical analysis and medical writing 5 –May‐09 y Jubilant Organosys Ltd, through its Bangalore, based subsidiary, Jubilant Biosys Ltd, has signed a  g y g g y y g research collaboration agreement with, AstraZeneca, focused on delivering novel drug candidates into  the international pharmaceutical company's pre‐clinical pipeline  10 – April‐09 Suven Life Sciences has completed its phase one multiple ascending dose study of SUVN‐502 in  healthy volunteers. SUVN‐502 is a potent, safe, highly selective, brain penetrant and orally active  antagonist at a non peripheral CNS receptor site 5‐HT6, intended for the symptomatic treatment of  t it t i h l CNS t it 5 HT6 i t d d f th t ti t t t f Alzheimer's disease, Schizophrenia and other disorders of memory 23‐Jan‐09 Syngene, Biocon's (India) contract research firm, has signed a partnership deal with U.S. biotech firm Sapient Discovery 9‐Jan‐09 India's Ranbaxy Laboratories Ltd commenced initial‐stage clinical trials on an experimental respiratory  I di ' R b L b i Ld di i i l li i l i l i l i inflammation drug it which it is  jointly developing with Britain's GlaxoSmithKline  29‐Sep‐08 India's Orchid Chemicals & Pharmaceuticals Ltd and U.S based Merck & Co Inc announced drug  discovery pact to develop new drugs to treat bacterial and fungal infections. Orchid's research unit,  Orchid Research Laboratories, will identify drug targets and develop them through phase II clinical  , y g g p g p trials and Merck will conduct late‐stage clinical trials and sell the drugs after regulatory approvals  CLINICAL TRIALS MARKET – INDIA.PPT 34
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